SPL v2
SPL
SPL Set ID 1b9db681-a297-5aa9-e063-6394a90a80ea
Route
TOPICAL
Published
Effective Date 2024-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Alcohol Glycerin Polysorbate 20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-24

Description

LIDOCAINE 5%

Purpose

lieduce pain and swelling during tattouermanent cosmetics,electrolysis other pain sensitive procedures


Medication Information

Purpose

lieduce pain and swelling during tattouermanent cosmetics,electrolysis other pain sensitive procedures

Description

LIDOCAINE 5%

Uses

After cleaning the skin, apply an appropriate amount of gel to the area to be treated.

Massage gently for a few minutes and wait for 15 to 30 minutes for the gel to take effect as an anesthetic.

Dosage

Squeeze out an appropriate amount of product and spread evenly on skin.

Section 51945-4

Warnings

For external use only.

Do Not Use

on damaged or broken skin.

Active Ingredients

LIDOCAINE 5%

Inactive Ingredients

WATER 36.7%

ALCOHOL 15%

POLYSORBATE 20 3%

GLYCERIN 20%

PROPYLENE GLYCOL 10%

YUCCA GLAUCA ROOT EXTRACT 2%

ACHILLEA MILLEFOLIUM FLOWER EXTRACT 3%

CAPRYLYL GLYCOL 0.3%

DISODIUM EDTA 0.2%

PHENOXYETHA-NOL 0.3%

CARBOMER 3.5%

TRIETHANOLAMINE 1%

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

rash occurs.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

After cleaning the skin, apply an appropriate amount of gel to the area to be treated.

Massage gently for a few minutes and wait for 15 to 30 minutes for the gel to take effect as an anesthetic.

Dosage

Squeeze out an appropriate amount of product and spread evenly on skin.

Section 51945-4 (51945-4)

Purpose

lieduce pain and swelling during tattouermanent cosmetics,electrolysis other pain sensitive procedures

Warnings

For external use only.

Do Not Use (Do not use)

on damaged or broken skin.

Active Ingredients (Active ingredients)

LIDOCAINE 5%

Inactive Ingredients (Inactive ingredients)

WATER 36.7%

ALCOHOL 15%

POLYSORBATE 20 3%

GLYCERIN 20%

PROPYLENE GLYCOL 10%

YUCCA GLAUCA ROOT EXTRACT 2%

ACHILLEA MILLEFOLIUM FLOWER EXTRACT 3%

CAPRYLYL GLYCOL 0.3%

DISODIUM EDTA 0.2%

PHENOXYETHA-NOL 0.3%

CARBOMER 3.5%

TRIETHANOLAMINE 1%

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)